Long-term safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24-week phase III trials followed by a 78-week open-label extension.

摘要: Summary Aim:  The aim of this study was to evaluate the long-term safety, tolerability and efficacy dipeptidyl peptidase-4 inhibitor linagliptin given either alone or in combination with other oral glucose-lowering agents persons type 2 diabetes. Methods:  A 78-week open-label extension evaluated subjects who participated one four preceding 24-week, randomised, double-blind, placebo-controlled parent trials received linagliptin, linagliptin + metformin, linagliptin + metformin + a sulphonylurea linagliptin + pioglitazone (all administered orally once daily). Individuals receiving these treatments during a previous trial continued same treatment (n = 1532) for up total 102 weeks, whereas those previously placebo were switched (n = 589). All 2121 participants at least dose medication included primary safety analysis. Results:  In active treatment, glycosylated haemoglobin A1c reduction achieved 24-week sustained through period (change from baseline week 102: −0.8%). Drug-related adverse events experienced by 14.3% participants. Hypoglycaemia occurred 13.9% similar between (13.6%) switching (14.6%). most frequently use metformin + a background therapy (11%). Overall, no clinically relevant changes body weight observed. Conclusion:  Long-term well tolerated change profile observed study. Sustained glycaemic control maintained 102 weeks monotherapy agents.